The therapeutic protein market is estimated to surpass $90 billion by 2010. Anonymous. “Therapeutic Proteins: Research Report” Lead Discovery Ltd. (2005). Therapeutic proteins such as hormones, enzymes, peptides and antibiotics for use in disease therapy have been extracted from human plasma, animal tissues, or produced by recombinant DNA technology. These proteins are used to treat various cancers, heart attacks, stroke, cystic fibrosis, Gaucher's disease, diabetes, anemia and hemophilia. It is important that such products are free of blood-borne pathogens derived from human and animal tissues, thereby making manufacturing costs and capacity concerns that affect the successful commercialization of the therapeutic protein market.
Presently, an inadequate protein supply and viral safety concerns surrounding plasmid-derived proteins have led to the development of recombinant production of therapeutic proteins. While genetically engineered plants, bacteria and yeast are adequate for producing simple mammalian proteins, they lack the cellular machinery to perform the complex protein glycosylation, carboxylation, assembly of subunits and folding (post-translational modification (PTM)), for biological activity.
Consequently, it is a long felt need in the art to develop technology such that large amounts of transgenic proteins may be economically collected and processed from non-human transgenic mammals.